Events

Retiro De Equipo (Recall) de BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    92404
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-04-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Leaking septa have been observed in manufacturing and also in customer complaints. health canada requested on december 16 2013 that "all users of the product" be notified of the situation an "informal notification" a "level ill recall". date problem was firstidentified: april 30 2012 how the problem was identified: during routine in-process leak inspection of product during manufacture. customer complaints: observed increased complaint rate for leakage during april-june 2012.

Device

BD NEXIVA CLOSED IV CATHETER SYSTEM - SINGLE PORT
  • Modelo / Serial
    Model Catalog: 383512 (Lot serial: >10 numbers contact mfg); Model Catalog: 383516 (Lot serial: >10 numbers contact mfg); Model Catalog: 383517 (Lot serial: >10 numbers contact mfg); Model Catalog: 383519 (Lot serial: >10 numbers contact mfg); Model Catalog: 383532 (Lot serial: >10 numbers contact mfg); Model Catalog: 383536 (Lot serial: >10 numbers contact mfg); Model Catalog: 383537 (Lot serial: >10 numbers contact mfg); Model Catalog: 383539 (Lot serial: >10 numbers contact mfg); Model Catalog: 383540 (Lot serial: >10 numbers contact mfg); Model Catalog: 383591 (Lot serial: >10 numbers contact mfg); Model Catalog: 383594 (Lot serial: >10 numbers contact mfg)
  • Descripción del producto
    BD Nexiva Closed IV Catheter System - Single Port
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.